FDA Inspection 1192369 — Northern VA Compounders PLLC
The FDA completed an inspection of Northern VA Compounders PLLC on December 9, 2022 in Sterling, VA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 9, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sterling, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18936 | FDCA 501(a)(2)(A) | Non-microbial contamination, production area |
| 18937 | FDCA 501(a)(2)(A) | Beta-lactam drugs, inadequate sanitation |
| 18938 | FDCA 501(a)(2)(A) | Hazardous drugs, prevention of cross-contamination |
| 18941 | FDCA 501(a)(2)(A) | Improper gowning, contamination |
| 18949 | FDCA 501(a)(2)(A) | First pass air blockage, open unit with sterile product |
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |
| 18963 | FDCA 501(a)(2)(A) | Inadequate HEPA filter, sterile product area |
| 18968 | FDCA 501(a)(2)(A) | Inadequate filter, final product sterilization |
| 21377 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical grade components |